BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 24584409 · Received March 12, 2026

    Report

    Report Number
    1823260-2026-00889
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    February 19, 2026
    Report Date
    March 12, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 882379. THE EXPIRATION DATE WAS NOT PROVIDED. THE CALIBRATION RECOVERY DATA PROVIDED WAS WITHIN SPECIFICATION. THE QC RECOVERY DATA SHOWED SOME FLUCTUATIONS. THE CUSTOMER CHECKED THE CELL RINSE STATION AND PROBES AND FOUND THAT REAGENT PROBE HEAD WAS LOOSE AND NOT COMPLETELY LOCKED IN PLACE, AND THAT THE GEAR PUMP PRESSURE WAS LOW. THE CUSTOMER ADJUSTED THE REAGENT PROBE HEAD. THE MAINTENANCE ACTIONS PERFORMED BY THE CUSTOMER RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM GEN.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 6000 C501 MODULE. SAMPLE 1 HAD AN INITIAL RESULT OF 0.52 MMOL/L. THE CUSTOMER QUESTIONED THE RESULT WHICH PROMPTED THEM TO REPEAT THE SAMPLE. THE REPEAT RESULT WAS 2.48 MMOL/L. SAMPLE 2 HAD AN INITIAL RESULT OF 0.55 MMOL/L. THE CUSTOMER QUESTIONED THE RESULT WHICH PROMPTED THEM TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED ON ANOTHER C501 MODULE AND THE RESULT WAS 2.23 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643041 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown